BPN-Biologics Resources

Researchers participating in the Blueprint Neurotherapeutics Network for Biologics receive grant funding (a UG3/UH3 award or U44 award if a small business) and no-cost access to biotherapeutic development consultants and contract research organizations (CROs).

Research Grants (UG3/UH3 or U44)

All projects that enter BPN-Biologics begin with a UG3 phase (or U44 Phase I) of up to two years, which should be used to complete all lead optimization activities (for Discovery-stage projects) or any additional preparatory activities needed to initiate IND-enabling studies (for Development-stage projects). This phase will also be used to engage the LDT in establishing a detailed research plan and go/no-go milestones for all subsequent work.

Projects can enter BPN-Biologics during the Discovery or Development stage and may seek support through phase I/first-in-human testing. Discovery involves biologic agent characterization and optimization in order to identify a suitable development candidate. During the Development stage, a candidate undergoes preclinical toxicology testing required for an IND and manufacturing, ultimately advancing to phase I/first-in-human testing. BPN-Biologics-supported Development activities include chemical manufacturing and controls (CMC), formulation development, toxicology studies, regulatory support, and phase I/first-in-human testing.

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BPN-Biologics Projects Phase diagram

Consultants

Each Lead Development Team receives support from BPN-Biologics consultants. Consultants are assigned to a project with considerations for the project team's individual needs and consultants' expertise.

The list of consultants to be decided.

 

Contract Research Organizations

BPN researchers receive no-cost access to the network's Contract Research Organizations (CROs). LDTs plan and coordinate studies conducted by BPN CROs.

The list of CROs to be decided.

 

Informational Resources

NIH Stem Cell Information

FDA Guidance Documents

FDA CBER Standard Operating Procedures and Policies (SOPPs)

Example Target Product Profiles: Target Product Profile (TPP)(pdf, 189 KB) 

Example Agent Profiles: 

                   Example Antibody Profile(pdf, 100 KB) 
                   Example Antisense Oligonucleotide Profile(pdf, 105 KB) 
                   Example Viral Gene Therapy Profile(pdf, 118 KB) 
                   Example Peptide or Protein Profile(pdf, 100 KB) 

 

 

BPN-Biologics Staff

Program Director
Dr. Mario Skiadopoulos (Acting)

Health Program Specialist
Ms. Elena Barnaeva

Project Manager

Dr. Chris Boshoff

Operations Coordinator
Ms. Natasha Davis

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Form Approved OMB# 0925-0648 Exp. Date 06/2024